Kornimate/medical-research-clean huggingface dataset:
a phase i dose finding and safety study of oral lde225 in children and a phase ii portion to assess preliminary efficacy in recurrent or refractory mb

Conditions: Medulloblastoma; Rhabdomyosarcoma; Neuroblastoma; Hepatoblastoma; Glioma; Astrocytoma

Summary: phase i dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of lde225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on hedgehog signaling pathway. phase ii study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory mb.


Eligibility criteria:
inclusion criteria: * phase i - patients aged ≥12 months and \<18 years, phase ii - patients ≥12 months * phase i - histologically confirmed diagnosis of medulloblastoma, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, high grade glioma, or osteosarcoma, that has progressed despite treatment with standard therapies, or for which no standard treatments are available (patients with brainstem gliomas are excluded). phase ii - histologically confirmed diagnosis of recurrent or relapsed medulloblastoma with at least one measurable lesion. * performance status: karnofsky ≥60% for patients \>10 yrs, lansky ≥50 for patients less than or equal to 10 yrs * protocol-defined renal , liver and bone marrow function * negative pregnancy test before starting study treatment. if of child bearing potential must use 'highly effective' methods of contraception. * all patients must consent to provide a tumor sample exclusion criteria: * systemic anti-cancer treatment within 2 weeks prior to first dose (6 weeks for nitrosourea, mitomycin and monoclonal antibodies). * focal radiotherapy within 4 weeks prior to first dose, or full spinal radiotherapy within 3 months of first dose. * unresolved toxicity greater than ctcae grade 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia or other specifications in the eligibility criteria for this study), or incomplete recovery from previous surgery, unless agreed by novartis and the principal investigator (pi) and documented. * major surgery, serious illness or traumatic injury within 2 weeks of starting study therapy. patients anticipated to require major surgery within the first 2 cycles of treatment. * patients requiring a nasogastric tube for drug administration (g-tubes are permitted) * impaired cardiac function * pregnant or breast-feeding females * impairment of gastrointestinal (gi) function or gi disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: recurrent, refractory, medulloblastoma, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, astrocytoma, children, pediatric, hedgehog pathway inhibitor, adult
anti-diabetic effect of gynostemma pentaphyllum tea in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of gynostemma pentaphyllum (gp). this is a plant growing in the mountain regions of northern vietnam and previously being used in traditional medicine. the gp extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. all patients received instructions regarding diet and physical exercise. oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.

in vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. based on previous results in experimental animals, we have selected the plant gynostemma pentaphyllum (gp), which grows in the mountain region of northern vietnam. gp extract had a hypoglycemic effect on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin secretion. in addition, gp has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic zucker fatty rats. the present study aimed at investigate effects of gp extract, administered as a "tea", and compared with placebo in a randomized, double-blind trial in drug-naive patients with newly diagnosed type 2 diabetes. all patients also received instructions about diet and physical exercise. in addition to monitoring effects on plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Eligibility criteria:
inclusion criteria: * newly diagnosed, drug-naive patients with type 2 diabetes * fasting plasma glucose (fpg) 7.0-14.0 mmol/l * hba1c \> 6% exclusion criteria: * type 1 diabetes * liver failure * kidney failure

Keywords: herbal medicine type 2 diabetes insulin sensitivity insulin secretion
effects of iastm and vibration therapy in cervical disc herniation

Conditions: Intervertebral Disc Displacement; Neck Pain

Summary: this study investigates the effects of instrument-assisted soft tissue mobilization (iastm) and percussion massage therapy on pain, functional status, proprioception, and kinesiophobia in individuals with cervical disc herniation. a total of 66 participants diagnosed with cervical disc herniation will be randomly divided into three groups: vibration therapy, iastm, and conventional exercise. each group will receive conventional physiotherapy, while the intervention groups will additionally receive their respective therapies. outcomes will be measured using the visual analog scale (vas), neck disability index (ndi), laser pointer joint position sense test, and tampa scale for kinesiophobia (tsk). the aim is to evaluate and compare the effectiveness of both therapies in reducing pain, improving functionality and proprioception, and decreasing fear of movement.

cervical disc herniation is a common musculoskeletal condition that causes significant pain and functional limitations, often affecting individuals in their middle ages and those working in sedentary occupations. this study aims to investigate the therapeutic effects of two modern physical therapy techniques-instrument-assisted soft tissue mobilization (iastm) and percussion-based vibration therapy-on pain, functional capacity, proprioception, and kinesiophobia in individuals with cervical disc herniation. a total of 66 participants diagnosed with cervical disc herniation will be recruited and randomly assigned to one of three groups: (1) vibration therapy group, (2) iastm group, and (3) conventional exercise group. all participants will receive standard physiotherapy, including thermotherapy, tens, and range of motion exercises. intervention groups will additionally receive either percussion massage therapy (3 sessions/week for 3 weeks) or iastm (3 sessions/week for 3 weeks), targeting the cervical and upper back musculature. outcome measures will include the visual analog scale (vas) for pain, the neck disability index (ndi) for functional assessment, a laser pointer joint position sense test for proprioception, and the tampa scale for kinesiophobia (tsk) to assess fear of movement. the study seeks to compare the effectiveness of these approaches in improving clinical outcomes and contributing to evidence-based rehabilitation strategies for individuals with cervical disc pathology.

Eligibility criteria:
inclusion criteria: * have a diagnosis of cervical disc herniation. * have a complaint of neck pain lasting at least 3 weeks. * have a restriction in cervical range of motion. exclusion criteria: * have any additional orthopedic or neurological disorders besides cervical problems. * have a history of previous trauma to the cervical region. * have received physiotherapy within the past 6 months. * are unable to tolerate vibration therapy.

Keywords: cervical disc herniation neck pain instrument-assisted soft tissue mobilization vibration therapy proprioception kinesiophobia physiotherapy
effects of computer-assisted cognitive rehabilitation programs with breast cancer survivors

Conditions: Cognitive Impairment; Breast Cancer

Summary: potential study participants will be recruited at breast cancer survivor support groups. informed consent will be obtained with a form approved by the twu irb and participants will complete 4 tests. then participants will be randomly assigned to one of two computer-assisted cognitive programs. participants will be sent by email, exercises specific to their assigned computer-assisted cognitive program from happyneuron pro (http://ie.scientificbraintrainingpro.eu/). cognitive training on the computer entails 30 minutes a day, five times a week for one month. at the end of the study, the four pretests will be repeated, a satisfaction survey administered.

potential study participants will be recruited using a recruitment script and recruitment brochure at breast cancer survivor support groups. participants recruited to the study will be contacted to set up a pre-test data collection session. prior to any testing, informed consent will be obtained with a form approved by the twu irb. after informed consent is obtained participants will complete tests of digit span task, fact-cognitive function (version 3), quality of life patient/cancer survivor version and engagement in meaningful activities survey, and issued a tablet if they prefer. then participants will be randomly assigned to one of two computer-assisted cognitive programs. participants will be sent by email, exercises specific to their assigned computer-assisted cognitive program from happyneuron pro (http://ie.scientificbraintrainingpro.eu/). cognitive training on the computer entails 30 minutes a day, five times a week for one month. 6. at the end of the study, the four pretests will be repeated, a satisfaction survey administered, and any issued tablets collected. pre and post testing, obtaining of written consent, and issuing and returning a tablet will occur at the support group location. if this location is not available, they will occur at twu in a quiet room. if twu is not convenient to the participant, a quiet location that is suitable to maintain confidentiality for the participant will be chosen in collaboration with the participant.

Eligibility criteria:
inclusion criteria: * study participant self-identifies as breast cancer survivor * had treatment that may have included surgery, chemotherapy, radiation, pharmacological or any combination of these treatments * participant states has cognitive problems due to cancer treatment exclusion criteria: * persons who cannot read or understand spoken english * have disorders that may affect their cognition including major mental disorder, central nervous system disorders, alzheimer's disease, dementia, developmental delay, traumatic brain injury, or cerebrovascular accident.

Keywords: survivor cognitive rehabilitation
internet-delivered psycho-oncological support

Conditions: Cancer

Summary: cancer patients develop a high psychological burden of the underlying disease. to support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. the availability of internet-based psychotherapeutic support can bridge this gap. this study examines the effectiveness of mac-cbt® via the internet (called incobeth®) in cancer patients.

in this study, a randomized trial is conducted in which the online users are allocated into two different care services (mac-cbt® vs. psycho-educational support program). participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. all patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. initial will be done an extensive psychometric survey. the mac-cbt® group receives an intervention program based on ten modules, in which the aspects of mindfulness, acceptance and commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). the control group will have access to six modules with a psychoeducational support program, which is also constructed according to the mac principle. both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. the control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. input and output results are determined using validated survey instruments. randomisation is done by a physician not involved in the further course of the evaluation.

Eligibility criteria:
inclusion criteria: * cancer patient * psychological distress * informed consent exclusion criteria: * no informed consent * no cancer

Keywords: psychooncology mental health support icbt supportive treatment for cancer patients depression online-therapy psycho-oncological support via internet internet-delivered cognitive behavior medicine
peers and technology for adherence, access, accountability, and analytics (pt4a)

Conditions: Cardiovascular Disease; Hypertension

Summary: peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel while hit can support peer activities by facilitating targeted adherence counseling, teleconsultation, synchronization of clinical care, and pharmacy activities. the investigators have implemented a pilot program of door-to-door peer-based medication delivery and hit in western kenya, and preliminary data indicate improved adherence and blood pressure. however, the effectiveness of this implementation strategy is not fully established. therefore, the objective of the study is to use the precede-proceed framework to conduct transdisciplinary implementation research to test the hypothesis that integrating peer delivery of medications with hit (pt4a) improves medication adherence and reduces blood pressure among patients with uncontrolled hypertension in western kenya.

aim 1 will evaluate the effectiveness of pt4a by conducting a two-arm cluster randomized controlled implementation research hybrid type 2 trial, comparing pt4a to control. the primary biological outcome is one-year change in systolic blood pressure. the primary adherence outcome is the pill count adherence ratio. the primary implementation outcome is fidelity. secondary outcomes are blood pressure control, self-reported adherence, and re-aim metrics. aim 2 will evaluate potential mechanistic relationships between implementation measures and outcomes. sub aim 2.1 will evaluate if trust in the health system and patient activation mediate the relationship between pt4a and the outcomes. aim 3 will consist of cost-effectiveness, budget impact, and qualitative analyses to help inform adaptation of pt4a to other settings. the research will be conducted by a transdisciplinary team with diverse and complementary expertise. the investigators intend to add to existing knowledge of innovative and scalable strategies to improve medication adherence for global hypertension control.

Eligibility criteria:
inclusion criteria: • adult participants enrolled in ampath's cdm program with uncontrolled hypertension (sbp ≥ 140 or diastolic bp (dbp) ≥ 90) exclusion criteria: * hypertensive emergency requiring immediate medical attention, * terminal illness, and * inability to provide informed consent.
pharmacokinetics of adrenaline after administration of ars -1 in subjects with upper respiratory tract infection

Conditions: Upper Respiratory Tract Infection

Summary: this is a phase 1, single-dose, two-period study that will consist of a combined screening and baseline period and an open-label treatment period. subjects will be enrolled when they experience an upper respiratory tract infection with nasal congestion and edema.


Eligibility criteria:
inclusion criteria: * treatment period 1 only, subject has symptoms of an urti at time of dosing based on the clinical judgement and the positive infectious cause of urti to be confirmed by respiratory pathogens panel. * has body weight more than 55 kg for male and 50 kg for female and body mass index between 18 and 32 kg/m2, inclusive. * has no declared medical history of hypertension and cardiovascular disease in the last 10 years. * at screening, has stable vital signs in the following ranges (after 5 minutes of rest): * sbp ≥90 and ≤140 mmhg * dbp ≥50 and ≤90 mmhg * hr ≥45 and ≤100 beats per minute (bpm) * is a nonsmoker within the previous 2 months (calculated from first dosing) and does not use tobacco-containing products. exclusion criteria: * has a stated history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. * has current or past history of clinically significant asthma or angioedema. * has prior nasal fractures, severe nasal injuries or history of nasal disorders that could interfere with nasal spray administration. * has any clinically significant medical condition or physical exam (pe) finding as deemed inappropriate by the investigator. * has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ecg. * subject reports they have had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening. * subject reports they have donated blood including platelets or plasma only or had an acute loss of blood (\>50 ml) during the 30 days before study drug administration or intends to donate blood or blood products within 30 days after the completion of the study. * has a history (within 12 months before screening) of drug use, or has a positive test for drugs of abuse at screening or upon admittance to the study center, or has a stated history of alcohol abuse. * has been on an abnormal diet during the four (4) weeks from day 0. 10. has participated in a clinical trial within 30 days prior to the first dose of study drug. 11. has had treatment with any adrenaline or noradrenaline containing products within 7 days of day 0. 12. has inadequate or difficult venous access that may jeopardize the quality or timing of the pk samples.
efficacy and safety of nirmatrelvir/ritonavir for treating omicron variant of covid-19

Conditions: Omicron Variant of COVID-19

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of nirmatrelvir/ritonavir in the treatment of the omicron variant of covid-19. the main question it aims to answer is: whether the use of the drug can help patients recover from covid-19. patients in both groups were given lianhua qingwen capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature \>38.5 ℃. the study group was given nirmatrelvir 300mg/ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.


Eligibility criteria:
inclusion criteria: * confirmation of covid-19 infection within 24h and positive nasopharyngeal swab for covid-19 nucleic acid rna； * age ≥12 years and weight ≥ 40kg； * subjects of fertility must agree to use highly effective contraceptive methods. exclusion criteria: * previous history of covid-19 treatment； * the known history of active liver disease； * patients on renal dialysis or have moderate to severe impaired renal function； * the known human immunodeficiency virus (hiv) infection; * suspected or confirmed concurrent active systemic infections other than covid-19 infection； * allergy or other contraindication to any component of the study intervention; * any drug or substance that is currently or expected to be used that is a high reliance on cyp3a4 enzyme clearance or strong cyp3a4 enzyme inducers； * pregnant or breastfeeding women.

Keywords: nirmatrelvir/ritonavir covid-19
medication reconciliation at discharge: impact on patient's care

Conditions: Medication Reconciliation

Summary: patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. this risk may be linked with discontinuity of care between hospital physicians and primary care physician (pcp). the investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. to demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the pcp after discharge.

patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients and may lead to further hospitalization. this risk may be linked with discontinuity of care between hospital physicians and primary care physician (pcp) and from discrepancies between patient's current medications and drugs prescribed at discharge. preventing adverse drug events (ades) remains a patient safety priority not only in hospitals but also across the continuum of care for patients. implementing medication reconciliation at all transitions in care is an effective strategy for preventing discrepancies and ades. medication reconciliation prevents and corrects medication errors by promoting transmissions of complete and accurate information about medicines. furthermore, ades may be the result of a failure to understand and manage post-discharge care needs and can lead to hospital readmission. we assume that medication reconciliation at discharge, secondarily transmitted to the pcp with a discharge counseling session between the patient and a clinical pharmacist could have a positive impact on the maintenance of therapeutic optimization decided by in-hospital practitioners. in order to evaluate this assumption, we will conduct a randomized controlled study on 120 patients (as a reduction by 15% of the number of prescription changes not maintained by the pcp after discharge is expected). the follow-up will last 1 month after discharge from hospital. the first prescription from the pcp will be collected and analyzed. in addition, patients and pcps will be contacted by the pharmacist to answer specific questionnaires. the primary objective of the study is to assess the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * hospitalized in infectious disease department * with a chronic disease and a current medical prescription including at least three drugs * discharged home or nursing home * not opposed to the study exclusion criteria: * foreigners, patients under legal guardianship * advanced dementia (mms\<20) or phone tracking impossible * primary care physician opposed to answer questionnaire